Yes. We have invested over 40 million dollars in research, clinical studies and facilities to develop and test our human milk derived products. This world class research and development would not have been possible in a non-profit business model.

Prolacta has set up a network of affiliated milk collection organizations. These organizations can be found in hospitals, birthing centers, or associated with charities. Depending on the organization, they share the responsibilities of qualifying the donors and collecting the milk with Prolacta. All affiliated milk collection organizations have all milk sent to Prolacta for processing.

No. We are not involved with nor do we promote milk sharing. Human milk that is exchanged through informal processes may not always be screened, tested nor pasteurized. Additionally, the donors may not always be pre-screened or tested for viruses and drugs of abuse, which can be very dangerous to the recipient.

The milk that is collected through affiliated milk banks is tested, pasteurized and formulated into nutritional products exclusively for in hospital use. The formulations are made specifically to treat critically ill and premature babies that are in the NICUNICU
Neonatal/Newborn Intensive Care Unit.. The donations do not serve as substitutes for mother’s milk if a baby in not under hospital care.

Currently, there are no known side effects based on the six clinical trials and significant commercial use of the products. Prolacta continues to monitor the products in the same way that other therapeutic products are monitored.

Clinical trials were conducted which showed major improvements with the use of human milk fortifier (also commonly called breast milk fortifier) in growth and developmental outcomes for premature infants. Fortification is now considered standard of care for these infants and not to fortify their milk would be considered unethical under almost all circumstances.

The average baby that was evaluated in our clinical studies was approximately 950 grams (2.14 pounds) at birth. Prolacta recommends the use of its products in babies weighing 1250 grams (2.lbs. 12 oz) or less at birth.

Absolutely. A mother’s milk is the gold standard of nutrition. Prolacta’s human milk fortifier (also commonly called breast milk fortifier) was specially designed to be used with mothers’ own milk. This combination will provide infants with the best possible nutrition.

There are numerous studies that demonstrate the superiority of human milk over cow’s milk as the best nutrition for babies. These and other data have led the American Academy of Pediatrics to state that breastfeeding is important for optimal infant and child health. Additionally, a recently completed randomized, controlled clinical trial demonstrated that a completely human milk-based diet, including Prolact+ H2MF®Prolact+ H2MF®

For example, when we are filling Prolact+4® 20mL, the target fill for each bottle is 20.3mL. With this target, the amount dispensed by the filling unit is between 20.05mL and 20.6mL. This ensures that there will always be a minimum of 20mL of product dispensed in each bottle.

Always refer to the corresponding product insert of the formulation you are administering for proper use and administration of all Prolacta® products. If you would like to request more copies, please contact us at (626) 599-6260, info@prolacta.com or go to the Products page to download a PDF.

Yes, there are other fortifiers for preterm infants, but Prolact+ H2MF® is the only 100% human milk fortifier. Other fortifiers are made from cow’s milk. It has been shown that babies weighing between 500 g to 1250 g at birth, given a complete human milk diet including Prolact+ H2MF®, showed a 77% reduction in the odds of developing NEC when compared with to infants receiving human milk fortified with cow’s milk-based milk fortifier.

Yes. Prolacta products are regulated by the FDA. Prolacta’s facility is licensed as a tissue bank by the states of California, New York, and Maryland which all require such a license for human milk banking.

By concentrating human milk proteins and providing them in different volumes, Prolacta formulations give neonatologists the widest range of options to meet the latest nutritional recommendations for critically ill premature infants from leading neonatal experts.

Milk Banking

Breast milk donations follow a rigorous screening process based on the blood banking model. Prolacta is the only organization that uses these combined safety steps:

Potential breast milk donors are screened through a medical history survey. After the screening, the donor is entered into Prolacta’s secure database and assigned a donor number.

Once the potential donor passes the medical history survey, she must obtain written approval from her physician and her baby’s pediatrician before she can continue in the donation process.

The potential donor measures the temperature in her freezer with a thermometer provided by Prolacta. The temperature must be cold enough to store human milk or, unfortunately, the potential donor may not donate.

If the potential donor passes the screening and meets all of the requirements outlined above, she is qualified to be a breast milk donor for a four month period. After four months, if she wishes to continue donating, she must complete a new medical history survey and have another blood test.

If you have extra milk, it can be processed into specialty formulations for the nutritional needs of premature and critically ill infants in neonatal intensive care units. Many moms donate their extra milk to help babies in need because they have had a preterm baby in the past or know someone who has had that experience. Breast milk donors report a sense of satisfaction knowing they are providing their milk to help premature or sick infants.

Yes, Prolacta Bioscience is a for profit company that makes the only human milk-based human milk fortifier available for fragile premature babies. We have invested over 40 million dollars in research, clinical studies and facilities to develop and test our human milk derived products. This world class research and development would not have been possible in a non-profit business model

Yes, Prolacta sells its human milk fortifier and other human milk nutritional products to hospitals for use in their Neonatal Intensive Care Units. Due to the rarity and the severity of illness for these fragile babies, nutritional products such as these can be covered by insurance.

Prolact+ H2MF is the first and only human milk fortifier made from 100% human breast milk (as opposed to cow’s milk). Prolact+ H2MF is intended for critically ill and premature infants in the NICU. Prolacta also makes the only standardized human donor milk product, as well as other human milk nutritional products, to help meet the nutritional needs of very low birth weight babies, allowing them to have the full benefits of a 100% human milk diet. Although your donated milk forms the precious raw material needed by these infants, extensive testing, formulation and processing must be done so that doctors can feel confident that the human milk formulations they give their patients are as safe as possible. In order to provide this processing and formulation, millions of dollars were invested in processing equipment and testing. Much like the blood banking industry, the blood is donated by individuals, tested, processed and sold by blood processors.

Almost any nursing mother can become a breast milk donor. If you are healthy with a good medical history, you are a likely candidate. You will need to complete a medical survey, get medical confirmation from your doctor and your baby’s pediatrician, have your blood tested for diseases and give a cheek cell sample, all at no cost to you. You will be informed of any test results that would indicate a health problem so that you can follow up with your doctor. If all of your results are fine, you can begin donating.

Do not donate milk if your baby needs it. If you pump after you breastfeed, there is a good chance that your milk supply will increase, allowing you to donate. Additionally, if you maintain this practice, you will generate excess supply as your baby is weaned. Prolacta-affiliated milk banks only want excess milk.

You can donate previously collected milk as long as it is less than 10 months old and you become a qualified breast milk donor. Also, the following conditions must be met to accept previously collected milk.

If you become a qualified donor, all previously collected milk may be accepted if it was pumped under the same conditions (i.e. milk bank approved medical conditions) as when you became qualified.

All previously collected milk must have been frozen immediately after pumping and stored in clear, sealed bags or plastic bottles designed to store human milk (e.g. Lansinoh® breast milk storage bags). We cannot accept milk that was stored in reused food containers. For example, we cannot take milk that was stored in old dairy milk cartons or juice bottles.

All previously collected milk must have been continuously frozen since the time it was first pumped. The milk could never have been thawed and refrozen.

We can only accept milk with one pumping per container. Please do not store one container in the refrigerator and add to the container over multiple pumpings. The main reasons are to avoid excess bacterial growth that can occur along with increased chance of rancidity of the milk.

All previously collected milk should be fully dated with the month, day and year the milk was expressed. It is also very helpful if you can write the last five digits of your assigned donor number (you will be assigned a number as soon as you start the qualification process) on the container.

All previously collected milk must be received not later than 10 months from the date of expression. If you do not have a date of expression written on each bag, the milk expiration date will be determined by baby’s date of birth.

You should establish breastfeeding for your own baby before you begin donating. We recommend you wait three to four weeks after your baby’s birth to begin the application process to become a donor and then only do so if your baby is doing well and gaining weight.

When and how often you express your milk is up to you. Most donors find it easier to set a time each day to express milk. Most mothers have more milk in the morning, so mornings are a good time to pump. It can be harder to collect milk if you do not express it regularly. Some moms express from one breast while their babies feed from the other.

The milk bank will provide each donor with breast milk storage bags for storing their expressed milk once the donor becomes qualified. Donors will need to obtain a breast pump to express their milk for donation.

Ideally, each pump should be in a separate container that is frozen immediately after pumping. However, if you have previously collected milk and placed multiple pumpings into a single container, that milk is acceptable if: the container was placed in the freezer immediately after pumping and the additional freshly pumped milk was added to the frozen milk in the container at various intervals, OR, the container was kept in the refrigerator for no more than 12 hours and additional, freshly pumped milk was added at various intervals; then the container was placed and left in the freezer.

Check with your milk bank about any medications you are taking, including over-the-counter remedies (those you can buy without a prescription from your doctor). The milk bank will tell you whether you qualify to donate while taking your medications.

Expressing when you are away from home can help you maintain your milk supply, especially if you are away from your baby. However, any milk that is expressed while you are traveling cannot be donated because we cannot ensure that the temperature of the milk was properly maintained.

Prolacta provides all qualified donors with cold shipping containers to ship the breast milk directly to Prolacta Bioscience at no cost to you, and you don't even have to leave your home. Prolacta makes arrangements for your donations to be picked up from your doorstep.

Nearly all the breast milk donated will go to sick babies in hospitals after processing at Prolacta Bioscience. Following screening, testing, formulation and processing, the specialized milk formulations are sold to hospitals for use in the neonatal intensive care unit (NICU). A small portion of your donated milk may be used for going human breast milk research.

By offering access to a network of milk banks, Prolacta allows mothers to choose a milk bank with which she feels most comfortable or best meets her needs. Donors can choose to work with charitable milk banks, or they can choose to be compensated directly. Prolacta utilizes this diversity of milk banks to ensure a supply of milk for those infants who need it most.

Qualified milk is donated milk which has met all the qualification guidelines. This includes two main phases: qualification of the donor and qualification of the milk she donates. Qualification of the donor includes medical history screening, freezer qualification, DNA profile creation, and viral blood screening. After the donor qualification is completed, she may send her milk to the milk bank. Once the milk is received at Prolacta Bioscience it must undergo and pass several rigorous testing procedures, including but not limited to, bacterial screening, drug screening, and DNA matching. Upon successful completion of these screening procedures, the milk is considered qualified for use in making 100% human milk fortifiers and standardized human milk for use in the NICU.

There is no time limit on how long you can donate your milk. Since Prolacta Bioscience blends and formulates the milk specifically for preterm babies, there is less concern about minor variations in nutrients that may occur later in lactation.